Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.
FDA Recall Z-0764-05 · Posted 2005-04-27
Recalling FirmMMS Sales Corp
Recall StatusTerminated
Product CodeCAI
Date Initiated2005-02-21
Date Terminated2006-12-20
Product QuantityTotal for all products: 7455 cases (161,273 units)
Reason for Recall
Partial occlusion in the T-piece resulting in airway obstruction.
Firm Action
The firm initiated the recall on February 21, 2004 by letter to all consignees.
Root Cause
Other
Distribution Pattern
Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.